Not intended for US media
Oslo, Norway, 20 September 2013 - Algeta ASA (OSE: ALGETA), announced today that Bayer has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending radium Ra 223 dichloride (radium-223) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission (EC) on the approval is expected in the fourth quarter of 2013. Radium Ra 223 dichloride was approved by the US Food and Drug Administration (FDA) in May under the brand name Xofigo®.
The CHMP recommendation is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
Andrew Kay, Algeta's President & CEO, said: "Today's positive opinion from the CHMP marks an important step in the anticipated approval of radium-223 in Europe. This recommendation, soon after Xofigo's US approval and launch, again highlights the need for a new therapeutic option that has been shown to significantly improve survival in prostate cancer patients whose disease has spread to the bones. We are committed to working with Bayer to ensure patients and physicians in Europe gain access to radium-223 as soon as possible."
"This recommendation confirms the safety and efficacy of radium-223 as a potential treatment option for patients suffering from castration-resistant prostate cancer with bone metastases, a debilitating and potentially deadly condition," said Christopher Parker, MD, Principal Investigator of the ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, London, and The Institute of Cancer Research, London. "There are many men with this disease who could potentially benefit from the availability of radium-223 due to its unique ability to extend life and delay symptomatic skeletal events such as spinal cord compression and the need for external beam radiation therapy for bone pain."
About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223) is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorisation Application to the EMA for radium-223 in December 2012 and subsequently in other territories.
Radium-223 (as Xofigo® injection) is approved in the United States and is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
Radium Ra 223 dichloride (radium-223) is an alpha particle-emitting pharmaceutical. Its active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect. Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy. The alpha particle range from radium-223 is less than 100 micrometers (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.
In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US.
Xofigo® is a registered trademark of Bayer
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Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.
This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding our co-promotion of Xofigo in the US and Bayer's promotion of Xofigo in Europe. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, general economic and business conditions, the impact of competition, the ability to successfully commercialize Xofigo, the risk that costs associated with the co-promotion of Xofigo may be greater than anticipated, manufacturing capacity, risks in obtaining additional regulatory approvals for radium-223 and the other risks and uncertainties described in our annual report.